Pall Posidyne® ELD Filter - 0.2 micron Intravenous Filter for 96 Hour Use - PALL CORPORATION

Duns Number:002054419

Device Description: 0.2 micron Intravenous Filter for 96 Hour Use with Luer-Lock Outlet Port

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More Product Details

Catalog Number

ELD96NT

Brand Name

Pall Posidyne® ELD Filter

Version/Model Number

ELD96NT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K850825,K850825

Product Code Details

Product Code

FPB

Product Code Name

Filter, infusion line

Device Record Status

Public Device Record Key

f59fa397-0cab-4a26-becd-c740b7ac22d8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 01, 2016

Additional Identifiers

Package DI Number

30636207000126

Quantity per Package

40

Contains DI Package

00636207000125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"PALL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 48